Summary
The use of statistical methods across the product lifecycle has steadily increased since the adoption of ICH Q8 and publication of regulatory guidance’s for lifecycle process validation. This increase does not simply meet regulatory expectation; these methods are good business practice no matter what the product. In this 3 day course participants will learn the typical sampling and statistical methods to use across the product lifecycle to: identify optimal operating regions and inform the control strategy (enable QbD), determine acceptance criteria, demonstrate the process is capable of reproducible commercial manufacture, provide evidence of ongoing process control and respond proactively to process changes.
Learning Objectives
- The most common and powerful statistical methods and their primary sue across the product lifecycle
- The relationship of statistical methods and Quality Risk Management (QRM)
- Key reasons to use Deign of Experiments (DOE) for process development
- Modelling populations to assure quality
- Difference between hypothesis testing and equivalence testing for comparability
- Understanding the components of a sampling plan and associated acceptance criteria for Process Validation batches
- Distinguish between intra- and inter- batch variability and methods to assess each
- Elements and nuances of an Ongoing Process Verification (OPV) Program
- Combination of root cause analysis with data visualization to speed root cause identification
Key Topics
- Integrating data analytics to accelerate development, improve processes and reduce risk
- Ensure Quality by Design and Optimal Control Strategy
- Sampling and Acceptance Criteria
- Establishing comparability with equivalence testing
- Identifying Relative contribution of sources of variability
- Data visualization
- Ensuring ongoing quality
Who should attend?
Process Validation, Process Development, Manufacturing Science and Technology, Process Improvement, Quality Assurance, Data Scientist, CMC Statistician, Technology Transfer
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 30 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
